Direct Rx recalls duloxetine 30 mg capsules over impurity above FDA's recommended limit
The capsules contain an impurity called N-nitroso-duloxetine at a level above the interim limit the FDA recommends, and the notice lists manufacturing practice deviations as the reason for the recall.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
- Company
- Direct Rx
- Hazard
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Units
- 263 Bottles
- Where sold
- U.S. Nationwide
- FDA classification
- Class II · Ongoing
- Classified by FDA
- June 23, 2026
- Recall started
- June 22, 2026
- FDA enforcement report
- July 1, 2026
- Identifiers
- Codes: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
- FDA recall number: D-0617-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Classification
- Class II (Ongoing)
- Distribution
- U.S. Nationwide
- Quantity
- 263 Bottles
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